CAContact object
Competent federal higher authority ("Bundesoberbehörde- BOB")
Federal Institute for Drugs and Medical Devices*: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
+49-228-20730
+49-228-2075207
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Germany (DE)
BfArM is the CA for medicinal products and MD!
Competent federal higher authority ("Bundesoberbehörde- BOB"):
Federal Institute for Vaccines and Biomedicine: Paul-Ehrlich-Institute (PEI)
+49-6103-773114
+49-6103-771268
Paul-Ehrlich-Str. 51-59
63225 Langen
Germany (DE)
PEI is the competent authority for sera, vaccines, blood preparations, bone marrow products, tissue preparations, test allergens, test sera, test antigens, gene transfer medicinal products, somatic cell therapy medicinal products, xenogenic cell therapy medicinal products and genetically engineered blood components.
Competent regional authority ("Landesbehörde")
Competent regional authorities are provided on the ZLG website (German register of the competent authorities responsible pursuant to "Landesrecht")
Before commencing a clinical trial, the competent regional authority responsible under "Landesrecht" has to be notified by the investigator of the activity (see ZLG- German register of the competent authorities responsible pursuant to Landesrecht) in addition to the competent federal higher authority (BfArM or PEI). In most cases it is the local "Regierungspräsidium".
Robert Koch Instutite (RKI)
In case of clinical trials with human embryonic stem cells, advice from the RKI is required before the submission to the PEI or BfArM. The RKI deals with the execution of the authorisation procedure based on the Stem Cell Law as well as the maintenance of a register of stem cell lines used and approved in research.
German institute of medical documentation and information (DIMDI)
In case of multimodal trials, including those with a medical device, the sponsor has to submit the clinical trial to DIMDI.
Federal Office for Radiation Protection- BfS (Bundesamt für Strahlenschutz)
In case of multimodal trials using radiotherapy, the sponsor has to submit the clinical trial to BfS.